Nucalm Directions For Use

Transcript

Directions for Use NuCalm® is a revolutionary technology proven to naturally relax the body without drugs. The NuCalm system is a safe and effective anxiolytic clinical solution that rapidly and predictably creates a deeply relaxed state and maintains it for the entire procedure. The benefits of NuCalm for dental treatment include: • Significantly reduces patient's involuntary motor responses and anxious behaviors: o Reduces salivary flow o Reduces the gag reflex o Reduces tongue movement o Reduces white knuckling o Reduces flinching and startle responses o Reduces muscle tension in the head, neck, and jaw o Reduces chatting, bathroom breaks and other stalling tactics o Reduces the need to re-administer local anesthetic (slows metabolic rate) • Patients are manageable and compliant without being impaired or cognitively unavailable • NuCalm uses no narcotics or controlled substances – the system mimics the way the body naturally “winds downs” and prepares for sleep • Patients can come and go on their own with no recovery time or supervision required • Patients typically feel calm and refreshed after a procedure using NuCalm • There is no risk to the dental team administering NuCalm – they do not need to be in attendance or monitor the patient’s vital signs Indications The NuCalm proprietary orthomolecular formula (all-natural dietary supplements) has been developed over several years to maximize the body's natural relaxation response with NuCalm. The proprietary formula is only available in the NuCalm system and includes structured nutrient-sourced building blocks that rapidly enter the body and convert to powerful chemical messengers that interrupt the stress response at the midbrain and create relaxation. All components are essential ingredients and supplement the body’s natural chemistry to interrupt the stress response. The proprietary, all-natural NuCalm dietary supplements are governed by the FDA under GRAS ("Generally Recognized as Safe"). Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by the FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown www.nucalm.com | Phone: (877) 668-2256 | [email protected] |1 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use to be safe under the conditions of its intended use. For a GRAS substance, generally available data and information about the use of the substance are known and accepted widely by qualified experts, and there is a basis to conclude that there is consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use. For example, Vitamin A, Vitamin B12, Vitamin D, Citric Acid, Garlic, Whey, and Sucrose are all classified as GRAS substances. • The FDA has not evaluated this statement. This proprietary orthomolecular blend is not intended to diagnose, treat, cure, or prevent any disease. • The Cranial Electrotherapy Stimulation (CES) is a class IIIa medical device designed for the reduction of anxiety, depression and/or insomnia when administered by a licensed healthcare provider. The CES is an FDA-cleared device and is available in the NuCalm system by prescription only. • Light-blocking eye mask or tinted glasses are used to block light to the optic nerve resulting in an immediate increase (up to 30%) in alpha waves in the visual cortex of the brain. The light-blocking eye masks are not intended to diagnose, treat, cure, or prevent any disease. • Proprietary neuroacoustic software is designed to entrain brain wave function and lead the brain to pre-sleep alpha/theta states (4 Hz-12 Hz). The FDA has not evaluated this statement. This software is not intended to diagnose, treat, cure, or prevent any disease. Contraindications • Safety of the CES device has not been established in people who have a cardiac pacemaker, ventricular assist device (VAD), brain implant, or have been cautioned against the use of electrical appliances (such as electric shavers, hair dryers, etc.). In these cases we recommend the CES device NOT be used. • Safety of the CES device and all-natural dietary supplements has not been established in women who are pregnant or nursing. In these cases we recommend the CES device and dietary supplements NOT be used. • Safety of the CES device and all-natural dietary supplements has not been established in people under 12 years of age. In these cases we recommend the CES device and dietary supplements NOT be used. NOTE: For all contraindications, you can use the headset (neuroacoustic software), and light-blocking eye mask. This will aid in relaxation, but the effect will typically not be as profound as using all four components. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |2 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use Warnings • The NuCalm system should not be used while operating heavy equipment or driving. • If a headache develops during treatment, stop use until the headache has subsided. Safety Precautions • This product is intended to be used only as specifically outlined in these Directions for Use. Any use of this product inconsistent with the Directions for Use is at the discretion of the healthcare practitioner and is the sole responsibility of the practitioner. • Storage and shelf life: the proprietary orthomolecular formula (dietary supplements) should be stored at temperatures not exceeding 25°C/77ºF. Protect from moisture. Do not freeze. Shelf life is 3 years from date of manufacture printed on the bottle. • Check the CES device for low battery as indicated by the low battery indicator on the LCD. Failure to verify power may result in inadequate anxiolysis/relaxation. • DO NOT IMMERSE CES DEVICE IN WATER OR DISINFECTANT. Wipe; do not spray solution onto plastic parts. Prevent liquids from entering openings on the CES device, especially the socket for the electrical leads. • Should the CES device become damaged in any way do not attempt to operate the device unless thoroughly inspected and serviced by qualified Solace Lifesciences, Inc. service personnel. Contact Solace Lifesciences, Inc. at (877) 668-2256. Adverse Reactions • Electrical appliances can interfere with some cardiac pacemakers, ventricular assist devices, and brain implants. • The electrodes (CES patches) should be placed only on unbroken skin. • Adverse effects are usually mild and temporary. Adverse effects reported in similarly marketed CES devices are dizziness, skin irritation, and headaches. Installation NOTE: Upon receiving the NuCalm system, check the packaging and parts for any possible damage that may have occurred during shipment. If damage is found, please contact Solace Lifesciences, Inc. at (877) 668-2256. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |3 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use System Contents  Cranial Electrotherapy Stimulation (CES) device  Lead wire with pin connectors for use with the CES device  Headset with integrated proprietary neuroacoustic (wall charger and USB connector included)  1 bottle (60 tablets) of all-natural dietary supplements (20 applications)  20 applications of CES patches  NuCalm pouch to hang on back of the operatory chair  Light-blocking eye masks (these can be laundered on gentle cycle)  Pair of glasses with tinted lenses (for people with claustrophobia) NOTE: Fully charge the headset before first use. Operation Before administering NuCalm, review all contraindications with the patient and ask patient to test the light-blocking eye mask. If the patient is not comfortable with complete darkness, let them use the tinted glasses for eye protection. STEP ONE Pre-administer three (3) dietary supplements in a disposable dispenser cup. 1. Have the patient chew the dietary supplements completely (1 at a time or all at once) and hold the dissolved contents in their mouth for at least 90 seconds, swish like mouthwash, and then swallow. Let the patient ‘swish and swallow’ with water afterward. NOTE: Patient may drink water before and after administration of the supplements. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |4 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use STEP TWO Administer the CES device. PREPARATION 1. Before first use, remove the protective plastic film covering the display face of the CES device and insert a high quality 9V alkaline battery. Battery is housed in back of device. Observe proper + / - terminal alignment. 2. Ensure CES device has enough power. Low battery indicator blinks and beeps three times when battery life is low. For best results, use quality alkaline 9V batteries. 3. Insert the pin leads into the female connectors on the adhesive patches. Note that the red wire should go to the right ear and the black to the left. 4. To improve adhesion of the patches, it is helpful to wipe the area behind the patient's ears with an alcohol swab and immediately wipe with a dry tissue to remove skin oils and cosmetics. OPERATION 1. Attach lead wire to the top of the CES device and insert lead wires into patches. 2. Apply a patch to the soft spot directly behind each earlobe – between the mastoid process and the mandible with the long edge of the patch nestled against the crease of the earlobe with the wires coming forward. Route the connecting wire under the patient’s arm. 3. Turn on the CES device and press the START/STOP button. The power value will blink “0.0 mA”. 4. Press the "up" button two times to increase the micro-current to a steady “0.1 mA”. Do not increase level beyond the steady “0.1 mA”. Sensitivity to the CES stimulus varies from patient to patient. Most patients will not feel anything. The subsensory micro-current stimulation will have the desired therapeutic effect, even when undetected by patients. NOTE: The patient does not need to feel anything for the CES device to be effective. 5. Place the CES device in the NuCalm pouch hanging on the back of the dental chair. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |5 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use LOW BATTERY 1. The CES device is powered by a 9V battery housed in the back of the unit. When battery life is low, the unit will beep three times and a low battery indicator will be displayed on the screen. 2. To replace the battery, open the battery compartment cover on the back of the unit. Remove the old battery and insert a new, high quality 9V alkaline battery. Be sure to observe battery polarity. NOTE: Use caution when removing battery from battery compartment (excessive force may result in damage). TROUBLESHOOTING 1. If CES device fails to work properly check the battery. Replace battery if necessary. 2. Replace any damaged lead wires. 3. Make sure the patches are properly applied behind the patient's ears. If you have trouble with adhesion, place a small strip of surgical tape over each patch. 4. If your device still does not work after the preceding steps, contact Solace Lifesciences, Inc. at (877) 668-2256 to set up a repair service or replacement for your CES device. STEP THREE Administer the light-blocking eye mask or tinted glasses. 1. Ask the patient if they are OK with complete darkness. If so, use the light-blocking eye mask. If not, offer the glasses with tinted lenses ‘as eye protection’. 2. Ask the patient to put on the eye mask or glasses. If using the light-blocking eye mask, have them slide it up on their forehead until Step 4 is completed. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |6 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use STEP FOUR Administer the proprietary neuroacoustic software. The NuCalm® integrated headset is a multifunction unit that includes: • NuCalm proprietary frequency-following response neuroacoustic software tracks • Bluetooth • FM Radio PREPARATION 1. Fully charge the NuCalm integrated headset before using. Insert the charging cable into the headset USB socket and plug the other end into the USB wall charger. HEADSET CONTROLS 1. Mode navigation - Press and hold the volume wheel for 1 second to change modes (Bluetooth, NuCalm software tracks, FM radio). 2. Play/Pause - Press the volume wheel quickly to pause the NuCalm software. To resume play, press the volume wheel quickly. 3. Change Software Tracks - Slide the volume wheel quickly to the VOL(+) position and release. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |7 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use 4. Restart Software Track - Slide the volume wheel quickly to the VOL(-) position and release. 5. Volume Control – To raise the volume, slide and hold the volume wheel toward VOL(+). To lower the volume, slide and hold the volume wheel toward VOL(-). OPERATION 1. Turn on the headset - slide the ON/OFF switch located on the side of the right earpiece to ON. The display will read ‘HELLO’, then ‘DIS-connect’, then ‘Pairing’. This is the Bluetooth feature which is NOT used with NuCalm. Press and hold the volume wheel in for one (1) second to navigate to the NuCalm software tracks. 2. Select the NuCalm software track - slide the volume wheel quickly to the VOL(+) position and release to move to the next track. Repeat until you see the NuCalm software track you want to begin at. 3. Adjust the headset for comfort - put on the headset and adjust for comfort. Ensure the volume is comfortably loud. To raise the volume, slide and hold the volume wheel toward (+). To lower the volume, slide and hold the volume wheel toward (-). 4. Restart the NuCalm software track - always start the NuCalm experience at the beginning of a NuCalm software track. 5. Ask the patient to slide the eye mask over their eyes, adjust it for comfort, and allow themselves the opportunity to relax. NuCalm Protocol – Technique Tips • Before starting the administration of NuCalm, share with your patient that NuCalm will allow them to have a more comfortable, relaxing dental appointment. • While patient is chewing the dietary supplements and holding in their mouth for 90 seconds, swab with alcohol behind each ear, wipe immediately with a dry tissue, and apply CES patches, one behind each ear, on the soft spot between the mastoid process and the mandible. The long edge of the patches should nestle along the crease of the earlobe with the center of the patch directly over the soft spot. • Offer a drink of water after the dietary supplements are administered. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |8 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use • Recline patient to surgical position prior to putting on eye mask and headset. • Cover patient with a blanket to keep them comfortable and warm. • Tell patient: “Allow yourself the opportunity to relax. Close your eyes and relax your shoulders. We will let you know when we are going to get started”. • Let the patient know that you will touch them gently on the shoulder before giving verbal instructions during the procedure. Ending the NuCalm Session 1. Dim the operatory lights if possible 2. Turn off the CES device by sliding the main switch on the right side up. 3. Ask the patient to remove the NuCalm headset. 4. Turn off the NuCalm headset. 5. Remove the CES patches. Detach the CES patches from the lead wires and discard. 6. Ask patient to remove the eye mask or glasses but keep their eyes closed if they wish. 7. Remove the NuCalm pouch from the dental chair. 8. Wipe components with aseptic solution. 9. Charge the NuCalm headset if necessary. 10. Place NuCalm components back in their case. Asepsis After each use of NuCalm, wipe headset and glasses with aseptic solution. Clean any other components as necessary. Never spray solutions directly on components. www.nucalm.com | Phone: (877) 668-2256 | [email protected] |9 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use Registrations/Warranty Limited Warranty The manufacturer warrants equipment of its own manufacture to be free from defects in material and workmanship for one (1) year from date of shipment to original purchaser, subject to the terms and conditions of this warranty. Solace Lifesciences, Inc. will, subject to the terms of this warranty, replace or repair at Solace Lifesciences, Inc. the sole option, any part found to be defective. Buyer must return any part claimed defective to Solace Lifesciences, Inc., shipping prepaid. 1. This warranty is expressly in lieu of any other expressed or implied warranties, including any implied warranty of merchantability or fitness and any other obligations on the part of the seller. 2. Solace Lifesciences, Inc. shall have no obligation under this warranty if damage occurs because of improper handling or operation, abuse, misuse, unauthorized repairs made or attempted, or where equipment is operated above rated capacity. Telephone or letter shall first obtain authorization for the return of parts under this warranty from the Solace Lifesciences, Inc. customer service department. Details of the claimed defect must accompany the returned part. 3. Notice of Claims: Immediately upon receipt of the goods, buyers must inspect same. All claims, including claims for defective goods, must be made within five (5) days after buyer learns of the fact upon which such claims are based, but in no event later than one (1) year after buyer's receipt of the goods. All claims not made in writing and received within the period specified above shall be deemed waived. 4. Liability of Solace Lifesciences, Inc. for any and all losses and damage to the buyer, in any way arising out of, or connected with this transaction or with the use of the equipment, from any cause whatsoever, shall be limited to the repair or replacement of defective material or workmanship. In no event shall Solace Lifesciences, Inc. be liable for consequential or indirect damage. 5. The purchaser of this CES device assumes full liability for the consequence of misuse by him/herself and all risks in connection with use of the CES device by other individuals whose treatment is not under the direction or supervision of a physician or licensed healthcare professional required by Federal law. www.nucalm.com | Phone: (877) 668-2256 | [email protected] | 10 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use Technical Data Better Life Devices CES Device Power Source 9V alkaline battery Channel 1 Output Voltage 0.80 Vpp @ 500 Ω resistive load Maximum Output Current Selectable from 0.1 to 1.5 mA in steps of 0.05 mA Frequency 0.5 Hz Pulse Width 240 ms to 1 second Treatment Time Selectable from 15 to 420 minutes and continuous Wave Shape Symmetrical biphasic square wave NuCalm Integrated Headset Actuating Current ≤30mA Control Voltage 3.7V Type Stereo headphone Speaker Φ40mm Sensitivity 115dB S.P.L. 1KHz Resistance 32Ω Power Rating 20mW Power Capacity 100mW Cable Length 1.5m Microphone 4.5x2mm -58dB ± 3dB Plug Φ2.5mm www.nucalm.com | Phone: (877) 668-2256 | [email protected] | 11 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc. Directions for Use Contact Solace Lifesciences, Inc. 501 Silverside Road, #7 Wilmington, DE 19809 Phone: (877) 668-2256 [email protected] www.nucalm.com www.nucalm.com | Phone: (877) 668-2256 | [email protected] | 12 Part Number: E1010 | v 15.1 © 2015 Solace Lifesciences, Inc.